U.S. patent number 10,638,785 [Application Number 16/376,840] was granted by the patent office on 2020-05-05 for liquid dietary supplement formulation compositions.
This patent grant is currently assigned to Watermins, LLC. The grantee listed for this patent is Watermins, LLC. Invention is credited to Manpreet S. Wadhwa.
United States Patent |
10,638,785 |
Wadhwa |
May 5, 2020 |
Liquid dietary supplement formulation compositions
Abstract
Liquid dietary supplement formulation compositions that provide
dietary minerals and additional optional ingredients beneficial for
health; methods for manufacturing such compositions; and methods
for enabling convenient oral ingestion of the formulation
ingredients, by adding the same to drinking water, beverages,
foods, or meals. The inventive formulation compositions generally
include water, water-soluble calcium compound(s), water-soluble
magnesium compound(s), and additional optional ingredients, wherein
the sum of the concentrations of the calcium and magnesium
compounds is most preferably 2 molar or more, up to the point of
saturation. The inventive formulation compositions possess inherent
resistance to microbial growth. The inventive formulation
compositions and variations thereof can be used as dietary
supplements to increase take of beneficial minerals, to mineralize
water, to fortify foods or beverages, and can also be used to
prepare a variety of additional liquid formulations by varying the
calcium and magnesium compounds, and/or by adding one or more
compatible ingredient(s).
Inventors: |
Wadhwa; Manpreet S. (Thousand
Oaks, CA) |
Applicant: |
Name |
City |
State |
Country |
Type |
Watermins, LLC |
Newbury Park |
CA |
US |
|
|
Assignee: |
Watermins, LLC (Newbury Park,
CA)
|
Family
ID: |
48613137 |
Appl.
No.: |
16/376,840 |
Filed: |
April 5, 2019 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20190223487 A1 |
Jul 25, 2019 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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13712328 |
Dec 12, 2012 |
10251412 |
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61569790 |
Dec 13, 2011 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A23L
2/52 (20130101); C02F 1/68 (20130101); A23L
33/16 (20160801) |
Current International
Class: |
A23L
33/16 (20160101); A23L 2/52 (20060101); C02F
1/68 (20060101) |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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1274544 |
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Nov 2001 |
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CN |
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9721356 |
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Jun 1997 |
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WO |
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Other References
Anonymous: "Q & A: Salt's Effect on Water's Density |
Department of Physics | University of Illinois at
Urbana-Champaign", Oct. 11, 2014 (Oct. 11, 2014), XP055323069,
Retrieved from the Internet:
URL:https://web.archive.org/web/20141011160319/http://van.physics.illinoi-
s.edu/qa/listing.php?id=1524 [retrieved on Nov. 25, 2016]. cited by
applicant .
Anonymous: "Lactic Acid 88% USP Heat Stable", Nov. 25, 2016 (Nov.
25, 2016), pp. 1-1, XP055323063, Retrieved from the Internet:
URL:http://webcache.googleusercontent.com/search?q=cache:fxH-fUJOUKAJ:www-
.adm.com/layouts/pdf.aspx?techdocid=3908&src=E+&cd=3&hl=en&ct=clnk&gl=de
[retrieved on Nov. 25, 2016]. cited by applicant.
|
Primary Examiner: Dicus; Tamra L.
Attorney, Agent or Firm: Rankin, Hill & Clark LLP
Parent Case Text
CROSS REFERENCE TO RELATED APPLICATION
This application is a continuation of U.S. application Ser. No.
13/712,328, filed Dec. 12, 2012, now U.S. Pat. No. 10,251,412, and
claims priority to U.S. Provisional App. Ser. No. 61/569,790 filed
on Dec. 13, 2011.
Claims
The invention claimed is:
1. An aqueous composition comprising: a. water; b. one or more
dissolved calcium compound(s); and c. one or more dissolved
magnesium compound(s): wherein the one or more dissolved calcium
compound(s) are selected from calcium chloride and calcium acetate
and the one or more dissolved magnesium compound(s) are selected
from magnesium chloride and magnesium acetate, wherein the sum of
the concentrations of the dissolved calcium compound(s) and
dissolved magnesium compound(s) is from 1 Molar to the point of
saturation, wherein the molar ratio of calcium to magnesium is from
0.3 to 3.2, and wherein the calcium and magnesium compounds remain
stable in solution at room temperature for at least 3 months.
2. The composition of claim 1, wherein the sum of the
concentrations of the dissolved calcium compound(s) and dissolved
magnesium compound(s) is from 1 Molar to 4.2 Molar.
3. The composition of claim 1, wherein the sum of the
concentrations of the dissolved calcium compound(s) and dissolved
magnesium compound(s) is from 1.5 Molar to 4.2 Molar.
4. The composition of claim 1, wherein the sum of the
concentrations of the dissolved calcium compound(s) and dissolved
magnesium compound(s) is from 2 Molar to 4.2 Molar.
5. The composition of claim 1, wherein the calcium compound
comprises calcium chloride and the magnesium compound comprises
magnesium chloride.
6. The composition of claim 5, further comprising potassium
chloride.
7. The composition of claim 1, wherein one or more additional
compatible ingredient(s) is dissolved, solubilized, emulsified, or
suspended within the composition.
8. The composition of claim 1, wherein one or more of the dissolved
compounds is formed in situ within the composition.
9. A method of fortifying a beverage, comprising: adding at least 1
.mu.l up to 60 ml of the composition of claim 1 to 240 ml (one cup)
of the beverage; or adding correspondingly smaller or larger
amounts of the composition to smaller or larger quantities of the
beverage.
10. The method according to claim 9, comprising: adding at least 50
.mu.l (one drop), up to 30 ml of the composition of claim 1 to 240
ml (one cup) of the beverage; or adding correspondingly smaller or
larger amounts of the composition to smaller or larger quantities
of the beverage.
11. The method according to claim 10, wherein one or more
additional compatible ingredient(s) is dissolved, solubilized,
emulsified, or suspended within the composition.
12. A kit comprising the composition of claim 1.
13. The kit according to claim 12, wherein one or more additional
compatible ingredient(s) is dissolved, solubilized, emulsified, or
suspended within the composition.
14. A method for manufacturing the composition of claim 1, wherein
the composition is prepared by a process comprising one or more of:
mixing of ingredient(s) into water or aqueous solution; mixing of
one or more aqueous solution(s); or removing water from dilute
composition(s) by evaporation, dialysis, ultrafiltration, or
freeze-drying.
Description
FIELD OF THE INVENTION
The present invention relates generally to dietary supplements and
more specifically it relates to liquid dietary supplement
formulation compositions that generally include water-soluble
dietary minerals and additional optional ingredients that are
beneficial for health; methods of designing and producing such
formulation compositions, and methods to enable convenient oral
ingestion of the formulation ingredients, by adding the
formulations to drinking water, beverages, or meals.
BACKGROUND OF THE INVENTION
Calcium is the most abundant mineral in the body and plays both a
structural and functional role in maintaining human health. While
most of the body's calcium is stored in the bones and teeth,
calcium also serves a critical role in processes such as vascular
contraction and vasodilation, muscle function, nerve transmission,
and hormonal secretion. The calcium ion is also a ubiquitous
cellular messenger, and stimulates a variety of enzymes and other
target proteins.
There are a number of factors that put people at risk for diseases
associated with inadequate calcium intake. Calcium absorption
decreases in adulthood and continues to decrease as people age. In
aging adults, bone breakdown exceeds formation, resulting in bone
loss. In women, menopause leads to bone loss because decreases in
estrogen production both increase bone resorption and decrease
calcium absorption. Negative effects on calcium balance have also
been observed in amenorrhic women of childbearing age. Further, a
number of people who avoid dairy products due to lactose
intolerance or veganism are also at risk for calcium inadequacy.
Bone health measures serve as a basis for deriving measures such as
Recommended Dietary Allowances for calcium, and inadequate calcium
intake increases the risk for osteoporosis, a disorder
characterized by porous and fragile bones which affects more than
10 million U.S. adults. In addition to its effects on bone health,
calcium intake has been proposed to have beneficial effects on
reducing cardiovascular disease risk, lowering blood pressure, and
prevention of colorectal cancer and prostate cancer.
Magnesium is another essential mineral in the body. About half of
total body magnesium is found in bone, while the other half is
found within body tissues. Magnesium is required for more than 300
biochemical reactions in the body, and is important for maintaining
the function of muscles and nerves, supporting the immune system,
maintaining bone health, regulating blood sugar levels, maintaining
normal blood pressure, and playing a role in energy metabolism and
protein synthesis. Dietary studies suggest that many Americans do
not get adequate amounts of magnesium. As magnesium absorption is
regulated by the intestines and excretion is regulated by the
kidneys, conditions affecting these organs may result in magnesium
deficiency. For example, medicines that affect the kidneys such as
diuretics and some antibiotics and antineoplastic medications may
cause excessive loss of magnesium. Diabetes may result in magnesium
loss due to increased magnesium loss in urine due to hyperglycemia.
Alcoholism is associated with low blood levels of magnesium, and
individuals with chronic malabsorptive problems such as those with
Chrohn's disease, gluten sensitive enteropathy, regional enteritis,
or intestinal surgery are also at risk for magnesium
deficiency.
Given the number of people at risk for calcium and magnesium
deficiency, there is an ongoing need for effective dietary
supplements that can provide or improve an intake of these minerals
to help meet nutritional requirements while being convenient and
easy to use for the consumer. There are many dietary supplements
containing calcium and magnesium compounds that are commercially
available or described in prior literature. The vast majority of
these are solid dosage forms, such as tablets, capsules, or
powders. Although these supplements are relatively inexpensive,
they have some disadvantages. Absorption of the nutrients from
these supplements tends to be quite variable, and large tablets or
capsules are frequently not suitable for pediatric, geriatric and
some patient populations. Liquid dosage forms of calcium and
magnesium possess some advantages over the solid dosage forms in
terms of better absorption, convenience of use and dosing
flexibility, but are less commonly available. The liquid
formulations tend to have stability limitations and are vulnerable
to microbial growth in the absence of additional preservatives.
Almost all marketed liquid formulations of calcium and magnesium
are particulate suspensions that tend to settle, and carry a
requirement to "shake well before use". These products can have
variable absorption, depending upon the suspension characteristics,
and can lead to incorrect dosing if not shaken well prior to use.
There are few liquid products where the calcium and magnesium are
completely dissolved in water and present in an ionic state to
provide optimal absorption upon ingestion. However, the calcium and
magnesium mineral concentrations of such formulations are
relatively low compared to those of the suspension liquid products,
and thus require relatively large volume dosages to meet the
recommended daily allowances. Thus, there is a need for improved
liquid dietary supplement formulations where calcium and magnesium
are present in relatively high concentrations, are completely
dissolved, and are inherently stable and resistant to microbial
growth.
BRIEF SUMMARY OF THE INVENTION
The invention generally relates to liquid dietary supplement
compositions which include water, water-soluble calcium
compound(s), water-soluble magnesium compound(s), and optional
ingredients. The total sum of concentrations of the dissolved
calcium and magnesium compounds is higher than the dissolved
concentrations found in currently available liquid supplements, and
is at least 1 Molar. These compositions possess resistance to
microbial growth which allows reduction or elimination of
additional preservatives in the compositions. Thus the compositions
possess some useful features that are not found in the existing
soluble liquid compositions of calcium and magnesium.
There have thus been outlined, rather broadly, some of the features
of the invention in order that the detailed description thereof may
be better understood, and in order that the present contribution to
the art may be better appreciated. There are additional features of
the invention that will be described hereinafter. In this respect,
it is to be understood that the invention is not Limited in its
application to the details of construction or to the arrangements
of the components set forth in the following description. The
invention is capable of other embodiments and of being practiced
and carried out in various ways. Also, it is to be understood that
the phraseology and terminology employed herein are for the purpose
of the description and should not be regarded as limiting.
An object of the invention is to provide liquid dietary supplement
formulation compositions that are beneficial for health, and a
convenient method of orally ingesting these supplements by adding
to drinking water or other suitable beverages.
Another object is to provide formulation compositions that are
useful for adding beneficial minerals to distilled, reverse-osmosis
filtered or otherwise deionized waters, in order to make these
waters more beneficial for health.
Another object is to provide formulation compositions that can be
used as liquid dietary supplements to increase intake of minerals
that are beneficial for human health.
Another object is to provide liquid formulation compositions that
inhibit or prevent microbial growth, and into which additional
compatible minerals, vitamins, and/or other useful ingredients can
be added to enable a variety of liquid dietary supplements.
Another object is to provide a method of designing a variety of
additional formulation compositions by building upon the basic
calcium and magnesium formulation compositions disclosed in this
invention, and variations thereof.
Another object is to provide methods of preparing or manufacturing
the above-mentioned formulations.
Another object is to provide formulation compositions that allow
convenient methods of oral consumption of the formulation
ingredients by diluting or mixing relatively small quantities of
the formulation compositions into drinking water, juices, other
beverages, or foods.
Another object is to provide methods of fortifying a beverage or
food by adding relatively small quantities of the formulation
compositions into drinking water, juices, other beverages, foods or
meals.
Another object is to provide kits as a convenient means for
fortifying a beverage or food at point of consumption, or for
fortifying a beverage or food at point manufacture for subsequent
distribution.
Other objects, advantages and variations of the present invention
will become obvious to those familiar with the art, and it is
intended that these objects, advantages and variations are within
the scope of the present invention. To the accomplishment of the
above and related objects, this invention may be embodied in the
form described in the accompanying embodiments and examples,
attention being called to the fact however, that these are
illustrative only and non-limiting.
DETAILED DESCRIPTION OF THE INVENTION
A. Definitions
"Water" as used herein refers to purified water which is suitable
for drinking and is reasonably free of contamination from
extraneous matter or dissolved substances that could react
unfavorably with the other ingredients of the formulations
described.
"Water solubility" as used herein means the maximum amount of a
compound or ingredient that will dissolve in pure water at a given
temperature.
"Water soluble" (or "water-soluble") as used herein means an
ingredient, element or material capable of dissolving in water, by
going into a liquid aqueous state, either spontaneously or by
employing commonly used methods to aid dissolution such as shaking,
mixing, heating, cooling, and adjusting water pH with an acid or
base to make the water acidic or alkaline.
The term "stable" as used herein means formulations capable of
maintaining their dissolved ingredients in solution without
precipitating those ingredients out for a minimum of 3 months, more
preferably at least 6 months, even more preferably 9 months and
most preferably 12 months or more.
The term "room temperature" as used herein is the commonly accepted
range from 59.degree. to 77.degree. F. (15.degree. to 25.degree.
C.) which is suitable for human occupancy and at which laboratory
experiments are usually performed.
The term "beverage" as used herein means water or any other potable
liquid suitable for human or animal consumption in a
ready-to-serve, drinkable form.
The term "clear" as used herein means transparent, with few or no
visible particulates present, and indicative of formulations with
fully dissolved ingredients.
"Saturation" or "point of saturation" as used herein means the
point at which water will not dissolve any more of a chemical in
solution.
As used herein, an ingredient of a formulation composition of the
invention is "compatible" with the composition when it can be
incorporated into the composition without making the resulting
composition unsuitable for its intended use.
"Compound" as used herein refers to a material, element or
ingredient. For example, a calcium compound refers to a calcium
containing material that is either naturally occurring or
chemically synthesized, either organic or inorganic in nature, and
includes materials or ingredients referred to by specialized terms
such as chemicals, salts, complexes, chelates, isomers, acids,
bases etc.
"Molar" or "Molarity" as used herein is a unit of concentration,
and refers to the number of moles of solute divided by the number
of liters of solution.
"Cup" as used herein means a volume of 8 fluid ounces or about 240
milliliters. "Cup" may also refer to a drinking vessel that holds
the same volume.
"Serving" of food as used herein refers to the portion of food used
as a reference on its nutrition label, or is the typical
recommended portion of that food to be eaten.
"RDA" as used herein refers to recommended dietary (or daily)
allowance, the amount of nutrient intake per day considered
necessary for maintenance of good health as set forth in the
Recommended Dietary Daily Allowance--Food and Nutrition Board,
National Academy of Sciences--National Research Council.
"Juice" as used herein has a meaning ascribed to it by a person of
ordinary skill in the art and includes a full strength juice a
juice drink containing less than 100% juice, a concentrate of
juice, or a diluted juice from fruits, vegetables or other produce,
which can be squeezed and/or crushed to produce a juice.
"Fruit flavor" as used herein refers to those flavors derived from
the edible reproductive part of a seed plant, especially one having
a sweet pulp associated with the seed. Also included within the
term "fruit flavor" are synthetically prepared flavors made to
simulate fruit flavors derived from natural sources.
"Botanical flavor" as used herein refers to flavors derived from
parts of a plant other than the fruit. As such, botanical flavors
can include those flavors derived from essential oils and extracts
of nuts, bark, roots and leaves. Also included within the term
"botanical flavor" are synthetically prepared flavors made to
simulate botanical flavors derived from natural sources.
"Flavonoid" as used herein refers to a group of phenol-containing
compounds found in plants that may be beneficial for health, and
are also sometimes referred to as bioflavonoids, flavanols,
flavonols, flavones, isoflavonoids, neoflavonoids, and
polyphenols.
"Emulsion" as used herein refers to a dispersion of minute droplets
of one liquid in another liquid, the two liquids being poorly
miscible or immiscible with each other, and "emulsification" refers
to any process of producing an emulsion.
"Suspension" as used herein refers to a dispersion of small
particles of a solid in a liquid, the solid being poorly soluble or
insoluble in the liquid. "Suspension" may also refer to any process
of producing a suspension.
"Solubilization" or "Solubilize" as used herein refers to making
insoluble or poorly soluble substance more soluble, by the addition
of solubilizing agent(s) such as detergents or co-solvents.
"Fortify" as used herein refers to increasing, improving or
supplementing the nutritious value of a food or beverage by adding
minerals, vitamins etc.
In certain jurisdictions, (here may not be any generally accepted
definition of the terra "comprising." As used herein, the term
"comprising" is intended to represent "open" language which permits
the inclusion of any additional elements.
Additional self-explanatory terms, and terms commonly used in the
art are utilized at various places in the application.
B. Main Elements of the Formulation Compositions
The formulation compositions of this invention have four major
categories of ingredients that are described in more detail below.
These comprise water water-soluble calcium compound(s),
water-soluble magnesium compound(s), and optional compounds or
ingredients that will be described further. The calcium and
magnesium compounds are dissolved within water so that the sum of
their concentrations is at least 1 Molar or more; and additional
compounds may also be present. All of the compounds or ingredients
are preferably obtained from food grade or higher quality sources.
Alternatively, the compounds are from lower quality sources, but
amenable to purification to make them suitable for human or animal
use. The compounds may be inorganic or organic, may exist as
anhydrous or hydrated forms, as D or L isomers, as mixtures, and in
liquid, solid or gas states.
1. Water
Water (of suitable purity) is chemically denoted as H.sub.2O and
comprises the first main element. Water is required as a solvent
vehicle for the various formulation compositions described in this
invention. Various methods of producing purified water are known in
the art and include filtration, deionization, reverse-osmosis,
distillation, among others. Purified water may also be obtained
from a natural, reasonably pure source such as from rain or
snow.
2. Water-Soluble Calcium Compound(s)
Water-soluble calcium compound(s) such as calcium chloride
comprises the second main element. The second main element provides
calcium which is an essential mineral for human and animal health.
There are many water-soluble calcium compounds suitable for oral
ingestion within a dietary supplement. The water-soluble compounds
may be inorganic or organic, and may exist as anhydrous or hydrated
forms, or as D or L isomers. These may all be used in the
formulation compositions of the invention, either as a single
calcium compound, or as a combination of calcium compounds,
provided that the selected ingredients are water soluble to some
extent and are compatible with the other dissolved ingredients in
the formulation. Various examples of calcium compounds are provided
later in this application.
3. Water-Soluble Magnesium Compound(s)
Water-soluble magnesium compound(s) such as magnesium chloride
comprises the third main element. The third main element provides
magnesium which is an essential mineral for human and animal
health. There are many water-soluble magnesium compounds suitable
for oral ingestion within a dietary supplement. The water-soluble
compounds may be inorganic or organic, and may exist as anhydrous
or hydrated forms, or as D or L isomers. These may all be included
in the formulation compositions of the invention, either as a
single magnesium compound, or as a combination of magnesium
compounds, provided that the selected ingredients are water soluble
to some extent, and are compatible with the other dissolved
ingredients in the formulation. Various examples of magnesium
compounds are provided later in this application.
4. Optional Ingredients
The formulation compositions of this invention may have additional
optional ingredients or compounds compatible with the
above-mentioned main elements (i.e. water, water-soluble calcium
compound(s) and water-soluble magnesium compound(s)). The optional
ingredients may be added, for example, to enhance the nutritional
profile of the composition or improve its organoleptic or
physicochemical properties. These optional ingredients may include
one or more additional compatible mineral(s), vitamin(s),
antioxidant(s), herbal extract(s), flavonoid(s), flavoring
agent(s), sweetener(s), bracer(s), buffering agent(s), coloring
agent(s), pH modifier(s), preservative(s), and the like. There is
no limit to the type or number of optional ingredients which may be
included, provided that they are suitable for use within a dietary
supplement, and are compatible with the other dissolved ingredients
in the formulation. Although it is preferable that the optional
ingredients are water soluble, even poorly soluble or
water-insoluble ingredients may be added, by utilizing co-solvents
or solubilizing agents, or by preparing suspensions or emulsions.
Various examples of optional compounds are provided later in this
application.
C. Some Examples of Calcium-, Magnesium-, and Optional
Compounds
Some examples of calcium compounds, magnesium compounds, and
optional compounds (including compatible mineral(s), vitamin(s),
antioxidant(s), herbal extract(s), flavonoid(s), flavoring
agent(s), sweetener(s), bracer(s), buffering agent(s), coloring
agent(s), pH modifier(s), preservative(s), and the like) that may
be included in the compositions of the invention are listed below.
It is to be understood that the listing of compounds is not
comprehensive, and represents commonly used compounds of varying
water solubility that may be suitable for human or animal use. When
present, the optional mineral(s), vitamin(s) etc. are typically
present in amounts sufficient to provide at least about 1%, more
preferably at least about 5%, still more preferably at least about
10%, even more preferably at least about 20%, and most preferably
at least about 30% of the RDA in a convenient ingestable volume
(e.g. about 1 teaspoon to 2 tablespoons, or about 5 to 30 ml) of
the formulation composition, where such RDAs are established. In
cases where no RDAs are established, such as in the case of many
types of optional compound(s) such as antioxidants, herbal
extracts, flavonoids, flavoring agents, sweeteners, bracers,
buffering agents, coloring agents, pH modifiers and preservatives,
those skilled in the art will understand and utilize amounts that
are generally safe and effective in providing the desired results.
Much information is available in the art that allows selection of
such amounts, and further, such amounts can also be selected or
varied by means of systematic experimentation.
1. Calcium Compounds
Non-limiting example of calcium compounds that may be included
include calcium acetate, calcium acetylsalicylate, calcium amino
acid complexes, calcium ascorbate, calcium aspartate, calcium
asparginate, calcium benzoate, calcium bicarbonate, calcium
bisglycinate, calcium bisulfite, calcium borogluconate, calcium
bromate, calcium bromide, calcium bromolactobionate, calcium
carbonate, calcium caseinate, calcium chlorate, calcium chloride,
calcium citrate, calcium citrate malate, calcium hydroxycitrate,
calcium potassium citrate, calcium cyclamate, calcium
diethylacetate, calcium ferrous citrate, calcium formate, calcium
fumarate, calcium glubionate, calcium glucarate, calcium
gluceptate, calcium gluconate, calcium glutamate, calcium
glycerophosphate, calcium glycinate, calcium hexametaphosphate,
calcium histidinate, calcium hydroxyapatite, calcium hydroxide,
calcium hypophosphite, calcium iodate, calcium iodide, calcium
ketoglutarate, calcium lactate, calcium lactate gluconate, calcium
lactate gluconate citrate, calcium lactobionate, calcium
laevulinate, calcium lysinate, calcium magnesium acetate, calcium
methionate, calcium malate, calcium methylfolate, calcium nitrate,
calcium nitrite, calcium orotate, calcium oxide, calcium
pantothenate, calcium perchlorate, calcium permanganate, calcium
picolinate, calcium pidolate, mono-, di- and tri-calcium phosphate,
calcium propionate, calcium pyruvate, calcium saccharin, calcium
silicate, calcium sodium lactate, calcium sorbate, calcium
spirulina chelate, calcium stearate, calcium stelate, calcium
succinate, calcium sulphate, calcium sulfite, calcium tartrate,
calcium threonate, and calcium ureidosuccinate.
2. Magnesium Compounds
Non-limiting example of magnesium compounds that may be included
include magnesium acetate, magnesium acetylsalicylate, magnesium
amino acid complexes, magnesium ascorbate, magnesium asparaginate,
magnesium aspartate, magnesium benzoate, magnesium bicarbonate,
magnesium bisglycinate, magnesium bromate, magnesium bromide,
magnesium carbonate, magnesium chlorate, magnesium chloride,
magnesium citrate, magnesium citrate malate, magnesium potassium
citrate, magnesium formate, magnesium fumarate, magnesium
gluceptate, magnesium gluconate, magnesium glutamate, magnesium
glycerophosphate, magnesium glycinate, magnesium histidinate,
magnesium hydroxide, magnesium hypophosphite, magnesium iodate,
magnesium iodide, magnesium lactate, magnesium lactate gluconate,
magnesium ketoglutarate, magnesium lysinate, magnesium malate,
magnesium nitrate, magnesium nitrite, magnesium orotate, magnesium
oxide, magnesium perchlorate, magnesium permanganate, magnesium
peroxide, magnesium picolinate, magnesium pidolate, mono-, di- and
tri-magnesium phosphate, magnesium propionate, magnesium pyruvate,
magnesium saccharin, magnesium salicylate, magnesium selenate,
magnesium potassium selenate, magnesium silicate, magnesium
succinate, magnesium sulfate, magnesium tartrate, magnesium
taurate.
3A. Other Mineral Compounds
Minerals other than calcium and magnesium are well-known in the
art. Examples of additional optional mineral(s) that may be
included include, but are not limited to, compounds of boron,
cobalt, copper, chromium, fluorine, iodine, iron, manganese,
molybdenum, nickel, phosphorus, potassium, selenium, silicon,
silver, sodium, strontium, sulphur, vanadium, zinc and other trace
minerals. These may all be used in the formulation compositions of
the invention, either as a single compound, or as a combination of
compounds, or by in-situ formation such as by a reaction between
acid and base, provided that the selected ingredients are
compatible with the other dissolved ingredients in the
formulation.
Non-limiting example of forms of boron that may be optionally
included include boric acid, boric anhydride, boron ascorbate,
boron gluconate, boric tartrate, sodium borate, sodium
tetrahydroborate, boron citrate, boron glycinate, boron aspartate
and boron amino acid complexes.
Non-limiting example of forms of cobalt that may be optionally
included include cobalt acetate, cobalt carbonate, cobalt chloride,
cobalt glucoheptonate, cobalt gluconate, cobalt sulfate, cobalt
amino acid complexes, cobalamin, cyanocobalamin, hydroxycobalamin
and methylcobalamin.
Non-limiting forms of copper that may be optionally included
include, copper bisglycinate, copper citrate, copper hydroxide
carbonate, copper sebacate, copper lysinate, copper gluconate,
copper sulfate, copper oxide and copper amino acid complexes.
Non-limiting examples of forms of chromium that may be optionally
included include chromic acetate, chromic chloride, chromic lactate
hydroxide, chromium nicotinate, chromic nitrate, chromium
picolinate, chromic sulfate, and chromium amino acid complexes.
Non-limiting examples of forms of fluorine that may be optionally
included include calcium fluoride, potassium fluoride, sodium
fluoride, and sodium monofluorophosphate.
Non-limiting examples of forms of iodine that may be optionally
included include potassium iodide, sodium iodide, potassium iodate,
sodium iodate, and iodine casein.
Non-limiting examples of forms of iron (ferrous and/or ferric) that
may be optionally included include iron bisglycinate, iron
carbonate, iron gluconate, iron sulfate, iron fumarate, iron
succinate, iron gluconate, iron lactate, iron tartrate, iron
taurate, iron ammonium citrate, iron citrate, iron pidolate, iron
picolinate, iron pyrophosphate, iron saccharate, and iron amino
acid complexes.
Non-limiting examples of forms of manganese that may be optionally
included include manganese aminoate, manganese ascorbate, manganese
bisglycinate, manganese aspartate, manganese arginate, manganese
picolinate, manganese carbonate, manganese chloride, manganese
citrate, manganese dioxide, manganese gluconate, manganese
glycinate, manganese glycerophosphate, manganese pidolate,
manganese sulfate and manganese amino acid complexes.
Non-limiting examples of forms of molybdenum that may be optionally
included include ammonium molybdate, molybdenum citrate, molybdenum
picolinate, potassium molybdate and sodium molybdate.
Non-limiting examples of nickel compounds that may be optionally
included include nickel chloride and nickel sulfate.
Non-limiting examples of forms of phosphorus that may be optionally
included include sodium, potassium, calcium and magnesium salts of
phosphoric acids and hydroxylapatite.
Non-limiting examples of forms of potassium that may be optionally
included include potassium bicarbonate, potassium carbonate,
potassium chloride, potassium gluconate, potassium
glycerophosphate, potassium hydroxide, potassium phosphate,
potassium citrate, potassium lactate, potassium malate, potassium
pyruvate, and potassium amino acid complexes.
Non-limiting examples of forms of selenium that may be optionally
included include include selenium oxide, sodium selenite, sodium
selenate, potassium selenide, and organic forms such as
selenomethonine and selenocysteine.
Non-limiting examples of forms of silicon that may be optionally
included include orthosilicic acid, silica hydride, silicon
dioxide, potassium silicate and sodium silicate.
Non-limiting examples of forms of silver that may be optionally
included include colloidal silver and silver chelate complexes.
Non-limiting examples of forms of sodium that may be optionally
included include sodium bicarbonate, sodium carbonate, sodium
citrate, sodium chloride, sodium gluconate, sodium lactate, sodium
hydroxide, sodium phosphate and sodium amino acid complexes.
Non-limiting examples of strontium that may be optionally included
include strontium carbonate, strontium lactate, strontium citrate,
strontium ralenate, and strontium gluconate.
Non-limiting examples of forms of sulphur that may be optionally
included include cysteine, methionine, and
methylsulfonylmethane.
Non-limiting examples of forms of vanadium that may be optionally
included include bis-oxovanadium, sodium metavanadate, vanadium
amino acid complexes, vanadium aspartate, vanadium citrate,
vanadium glycinate, vanadyl nicotinate, vanadyl sulfate.
Non-limiting examples of forms of zinc that may be optionally
included include zinc lactate, zinc sulfate, zinc chloride, zinc
acetate, zinc gluconate, zinc glycinate, zinc ascorbate, zinc
citrate, zinc arginate, zinc ascorbate, zinc aspartate, zinc
bisglycinate, zinc lysinate, zinc malate, zinc picolinate, zinc
pidolate, zinc orotate, zinc oxide and zinc amino acid
complexes.
3B. Vitamins and Antioxidants
Non-limiting examples of vitamins, antioxidants and related
compounds that may be optionally included in the formulation
compositions of the invention include biotin, carnitine, coenzyme
Q10, choline, folic acid, inositol, lycopene, lutein, astaxanthin,
zeaxanthin, vitamin A (beta-carotene, carotenoids, retinol,
retinol-acetate, retinol-palmitate), vitamin B.sub.1 (thiamine),
vitamin B.sub.12 (cobalamin, cyanocobalamin, dibencozide,
hydroxocobalamin, methylcobalamin), vitamin B.sub.2 (riboflavin),
vitamin B.sub.3 (niacin, niacinamide), vitamin B.sub.5 (pantothenic
acid, sodium pantothenate, calcium pantothenate, pantethine),
vitamin B.sub.6 (pyridoxine, pyridoxal, pyridoxal-5-phosphate,
pyridoxamine), vitamin C (ascorbic acid, ascorbate salts), vitamin
D (cholecalciferol, ergocalciferol), vitamin E (tocopherols,
tocotrienols), and vitamin K (phylloquinone, phtyomenadione,
menaquinone).
3C. Herbal Extracts and Flavonoids
Herbal extracts are well known in the art and are also referred to
as botanical extracts. Flavonoids are natural substances present in
a variety of plant sources (e.g., fruits, vegetables, and flowers),
and are suggested to be beneficial for health. They may also have
antioxidant activity. Herbal extracts and flavonoid(s) which may be
optionally included in the present invention can be extracted from,
for example, fruit, vegetables, green tea, plant parts or mixtures
thereof, by any suitable method well known to those skilled in the
art. Alternatively, specific herbal compound(s) or flavonoid(s) may
be prepared by synthetic or other appropriate biochemical methods
and incorporated into the present compositions. Non-limiting
examples of the most common flavonoids which are extracted from tea
plants and other plants include, for example, apigenin, catechins,
epicatechin, gallocatechin, epigallocatechin, epicatechin gallate,
epigallocatechin gallate, kaempferol, luteolin, myricetin,
quercetin, rutin, tannins, theaflavins.
3D. Flavoring Agents
Non-limiting examples of flavoring agents that may be included
include fruit flavors, botanical flavors, and the like.
Non-limiting examples of fruit flavors include orange, lemon, lime,
grapefruit, apple, grape, cherry, pineapple, fruit punch,
strawberry, kiwi, tangerine, raspberry, mango, cocoa, papaya,
apricot, passion fruit, and cupuacu. Non-limiting examples of
botanical flavors include kola, tea, aloe vera, guarana, ginseng,
ginkgo, hawthorn, hibiscus, rose hips, chamomile, peppermint,
fennel, ginger, licorice, lotus, schizandra, saw palmetto,
sarsaparilla, safflower, St. Johns Wort, curcuma, cardamom, nutmeg,
cassia bark, bunchu, cinnamon, jasmine, chrysanthemum, water
chestnut, sugar cane, lychee, bamboo shoots, vanilla, and
coffee.
3E. Sweeteners
The compositions of the present invention may optionally contain an
appropriate amount of one or more sweetener(s), including
carbohydrate sweeteners and natural and/or artificial no/low
calorie sweeteners. The amount of the sweetener used in the
compositions of the present invention typically depends upon the
particular sweetener used and the sweetness intensity desired.
The compositions of the present invention can be sweetened with any
of the carbohydrate sweeteners, preferably monosaccharides and/or
disaccharides. Preferred sugar sweeteners for use in compositions
of the present invention are sucrose, unrefined cane sugars, honey,
agave nectar, fructose, glucose, and mixtures thereof, particularly
sucrose and fructose. Fructose can be obtained or provided as
liquid fructose, high fructose corn syrup, dry fructose or fructose
syrup, but is preferably provided as high fructose corn syrup.
Non-caloric or low calorie sweeteners may optionally be used in the
compositions of the present invention to sweeten such compositions.
Non-limiting examples of such sweeteners include stevia,
erythritol, glycerin, licorice, glycyrrhizins, aspartame,
saccharine, cyclamates, acesulfame K, L-aspartyl-L-phenylalanine
lower alkyl ester sweeteners, L-aspartyl-D-alanine amides,
L-aspartyl-D-serine amides, L-aspartyl-hydroxymethyl alkane amide
sweeteners, L-aspartyl-1-hydroxyethylalkane amide sweeteners, and
synthetic alkoxy aromatics.
3F. Bracers
As is commonly known in the art, bracers can have a beneficial
physiological effect such as increased mental alertness. Bracers
can be obtained by extraction from a natural source or can be
synthetically produced. Non-limiting examples of bracers that may
be optionally included include methylxanthines, e.g., caffeine,
theobromine, and theophylline. Additionally, one or more of these
bracers are present in, for example, coffee, tea, kola nut, cacao
pod, mate, yaupon, guarana, puerh, and yoco. Natural plant extracts
from the above sources are the preferred sources of bracers as they
may contain other compounds that are also desirable.
The most preferred methylxanthine is caffeine. Caffeine may be
obtained from the aforementioned plants or, alternatively, may be
synthetically prepared. Preferred botanical sources of caffeine
which may be utilized as a complete or partial source of caffeine
include green tea, guarana, puerh, mate, black tea, cola nuts,
cocoa, and coffee. As used herein, green tea, guarana, coffee, and
mate are the most preferred botanical sources of caffeine, most
preferably green tea, guarana, and coffee. Any bracer utilized
herein is preferably present in physiologically relevant amounts,
which means that the sources used in the practice of this invention
provide a safe and effective quantity.
3G. Buffering Agents
Buffering agents are well known in the art; non-limiting examples
include carbonic acid, citric acid, acetic acid, phosphoric acid,
succinic acid and various salts of such acids.
3H. Coloring Agents
One or more coloring agent(s) may also be optionally included in
the formulation compositions of the invention. Coloring agents may
include FD&C Dyes, FD&C Lakes, or natural coloring agents.
Non-limiting examples of FD&C Dyes include FD&C yellow #5,
FD&C blue #2, and FD&C red #40. Non limiting examples of
FD&C Lakes include FD&C Lake red #40, FD&C Lake yellow
#6, and FD&C Lake blue #1. Non-limiting examples of natural
coloring agents include fruit, vegetable, and/or plant extracts
from sources such as grape, black currant, aronia, carrot,
beetroot, red cabbage, and hibiscus.
3I. pH Modifiers
Optionally, one or more pH modifier(s) may be included to raise or
lower the pH of the formulation compositions of the invention. The
pH of the formulation compositions may be lowered or raised for
organoleptic effects, or improving physicochemical properties such
as increasing solubility of the dissolved compounds. The pH
modifiers can be referred to as acidulants or alkalizing agents.
Non-limiting examples of acidulants are food grade edible acids
such as lactic acid, citric acid, malic acid, fumaric acid, adipic
acid, phosphoric acid, gluconic acid, tartaric acid, ascorbic acid,
acetic acid, succinic acid, and maleic acid. The pH of the
formulation compositions can be adjusted by varying the ratio of
cations (e.g. calcium, magnesium, sodium and potassium cations) to
acid components. Non-limiting examples of alkalizing agents are
compounds such as sodium hydroxide, potassium hydroxide, calcium
hydroxide and magnesium hydroxide.
3J. Preservatives
Non-limiting examples of preservatives that may be optionally
included in the formulation compositions of the invention include
acetic acid, citric acid, benzoic acid, sorbic acid, sulphur
dioxide, potassium benzoate, potassium sorbate, sodium benzoate,
sodium sorbate, calcium benzoate, calcium sorbate, sodium citrate,
potassium citrate, sodium hexametaphosphate, nitrites, sulfites
etc. Preservatives may also include antioxidants such as ascorbic
acid, EDTA, BHA, BHT, TBHQ, dehydroacetic acid, dimethydicarbonate,
ethoxyquin, and parabens.
B. Some Embodiments of the Formulation Compositions
1x. In one embodiment, the formulation composition is an aqueous
composition comprising the following ingredients, such that the sum
of concentrations of the dissolved calcium and magnesium compounds
is between about 1 molar to the point of saturation: a. water; b.
one or more dissolved calcium compound(s); and c. one or more
dissolved magnesium compound(s).
The sum of the concentrations of the dissolved calcium and
magnesium compounds is required to be at least about 1 molar or
more since this provides relatively high quantities of calcium
and/or magnesium in small volumes, while also providing microbial
resistance, as shown later in more detail.
2x. The composition of embodiment 1x, wherein the sum of the
concentrations of the dissolved calcium compound(s) and dissolved
magnesium compound(s) is in the range of about 1.5 molar to the
point of saturation.
3x. The composition of embodiment 1x, wherein the sum of the
concentrations of the dissolved calcium compound(s) and dissolved
magnesium compound(s) is in the range of about 2 molar to the point
of saturation.
4x. The composition of embodiment 1x, wherein the sum of the
concentrations of the dissolved calcium compound(s) and dissolved
magnesium compound(s) is in the range of about 1 molar to about 4.2
molar.
5x. The composition of embodiment 1x, wherein the sum of the
concentrations of the dissolved calcium compound(s) and dissolved
magnesium compound(s) is in the range of about 1.5 molar to about
4.2 molar.
6x. The composition of embodiment 1x, wherein the sum of the
concentrations of the dissolved calcium compound(s) and dissolved
magnesium compound(s) is in the range of about 2.0 molar to about
4.2 molar.
7x. The composition of embodiment 1x, wherein calcium and magnesium
are present in a molar ratio in the range of about 0.01 to 100
calcium to magnesium.
8x. The composition of embodiment 1x, wherein calcium and magnesium
are present in a molar ratio in the range of about 0.1 to 10
calcium to magnesium.
9x. The composition of embodiment 1x, wherein calcium and magnesium
are present in a molar ratio in the range of about 0.3 to about 3.2
calcium to magnesium.
10x. The composition of embodiment 1x, wherein the one or more
dissolved calcium compound(s) are selected from calcium chloride,
calcium acetate, calcium amino acid complexes, calcium amino ethyl
phosphate, calcium arginate, calcium aspartate, calcium ascorbate,
calcium citrate, calcium glubionate, calcium gluceptate, calcium
gluconate, calcium bromide, calcium iodide, calcium lactate,
calcium malate, calcium orotate, and calcium pyruvate; and the one
more dissolved magnesium compound(s) are selected from magnesium
chloride, magnesium acetate, magnesium amino acid complexes,
magnesium arginate, magnesium aspartate, magnesium ascorbate,
magnesium citrate, magnesium gluconate, magnesium glycinate,
magnesium lactate, magnesium lysinate, magnesium malate, magnesium
orotate, magnesium bromide, magnesium iodide, magnesium pyruvate
and magnesium succinate.
11x. The composition of embodiment 1x, wherein the one or more
dissolved calcium compound(s) are selected from calcium chloride
and calcium acetate; and the one or more dissolved magnesium
compound(s) are selected from magnesium chloride and magnesium
acetate.
12x. The composition of embodiment 1x, comprising the dissolved
compounds of calcium chloride and magnesium chloride.
13x. The composition of embodiment 1x, comprising the dissolved
compounds of calcium chloride, magnesium chloride, and potassium
chloride.
14x. The composition of embodiment 1x, further comprising one or
more additional compatible mineral(s), vitamin(s), antioxidant(s),
herbal extract(s), flavonoid(s), flavoring agent(s), sweetener(s),
bracer(s), buffering agent(s), coloring agent(s), pH modifier(s),
preservative(s).
15x. The composition of embodiment 14x, wherein the additional
compatible mineral(s) is one or more compound(s) of boron, cobalt,
copper, chromium, fluorine, iodine, iron, manganese, molybdenum,
nickel, phosphorus, potassium, selenium, silicon, silver, sodium,
strontium, vanadium, and zinc.
16x. The composition of embodiment 14x, wherein the additional
compatible vitamin(s), antioxidant(s), herbal extract(s) or
flavonoid(s) is one or more of biotin, carnitine, coenzyme Q10,
choline, folic acid, inositol, lycopene, lutein, astaxanthin,
zeaxanthin, vitamin A, vitamin B, vitamin B.sub.12, vitamin
B.sub.2, vitamin B.sub.3, vitamin B.sub.5, vitamin B.sub.6, vitamin
C, vitamin D, vitamin E, and vitamin K, apigenin, catechins,
epicatechin, gallocatechin, epigallocatechin, epicatechin gallate,
epigallocatechin gallate, kaempferol, luteolin, myricetin,
quercetin, rutin, tannins, and theaflavins.
17x. The composition of embodiment 14x, wherein the additional
compatible flavor(s) or sweetener(s) is one or more of: fruit
flavors of orange, lemon, lime, grapefruit, apple, grape, cherry,
pineapple, fruit punch, strawberry, kiwi, tangerine, raspberry,
mango, cocoa, papaya, apricot, passion fruit, and cupuacu;
botanical flavors of kola, tea, aloe vera, guarana, ginseng,
ginkgo, hawthorn, hibiscus, rose hips, chamomile, peppermint,
fennel, ginger, licorice, lotus seed, schizandra, saw palmetto,
sarsaparilla, safflower, St. Johns Wort, curcuma, cardamom, nutmeg,
cassia bark, bunchu, cinnamon, jasmine, chrysanthemum, water
chestnut, sugar cane, lychee, bamboo shoots, vanilla, and coffee;
carbohydrate sweeteners of sucrose, unrefined cane sugars, honey,
agave nectar, fructose, glucose, high fructose corn syrup;
non-caloric sweeteners of stevia, erythritol, glycerin, licorice,
glycyrrhizins, aspartame, saccharine, cyclamates, acesulfame K,
L-aspartyl-L-phenylalanine lower alkyl ester sweeteners.
L-aspartyl-D-alanine amides, L-aspartyl-D-serine amides,
L-aspartyl-hydroxymethyl alkane amide sweeteners,
L-aspartyl-1-hydroxyethylalkane amide sweeteners, and synthetic
alkoxy aromatics.
18x. The composition of embodiment 14x, wherein the additional
compatible bracer(s) is one or more of caffeine, theobromine,
theophylline, extracts of cocoa, coffee, tea, green tea, black tea,
guarana, kola nuts, cacao pods, mate, puerh, yaupon, and yoco.
19x. The composition of embodiment 14x, wherein the additional
compatible buffering agent(s), coloring agent(s), pH modifier(s),
or preservative(s) is one or more of: buffering agent of carbonic
acid, citric acid, acetic acid, phosphoric acid, succinic acid and
various salts of such acids; coloring agent of FD&C Dyes,
FD&C Lakes, or natural coloring agents such as fruit,
vegetable, and/or plant extracts of grape, black currant, aronia,
carrot, beetroot, red cabbage, and hibiscus; pH modifier of lactic
acid, citric acid, malic acid, fumaric acid, adipic acid,
phosphoric acid, gluconic acid, tartaric acid, ascorbic acid,
acetic acid, succinic acid, maleic acid, sodium hydroxide,
potassium hydroxide, calcium hydroxide and magnesium hydroxide;
preservative of acetic acid, citric acid, benzoic acid, sorbic
acid, sulphur dioxide, potassium benzoate, potassium sorbate,
sodium benzoate, sodium sorbate. TBIIQ, calcium benzoate, calcium
sorbate, sodium citrate, potassium citrate, sodium
hexametaphosphate, nitrites, sulfites, ascorbic acid, EDTA, BHA,
BHT, TBHQ, dehydroacetic acid, dimethydicarbonate, ethoxyquin, and
parabens.
20x. The composition of embodiment 1x, wherein one or more
additional compatible ingredient(s) are dissolved, solubilized,
emulsified or suspended within the composition.
21x. The composition of embodiment 1x, wherein one or more of the
calcium or magnesium compound, chelate or complex is formed in
situ, as may occur due to an acid-base reaction in water.
22x. The composition of embodiment 20x, wherein one or more of the
compound, chelate or complex is formed in situ, as may occur due to
an acid-base reaction in water.
E. Properties of the Compositions of the Invention
The elements of the formulation compositions need to be suitable
for consumption within a dietary supplement, sufficiently water
soluble to provide at least about 1 molar or higher summed
concentration of calcium and magnesium compounds dissolved in
water, and compatible with the other ingredients of the
formulation. There are several considerations for developing useful
liquid dietary supplement formulations. The major considerations
include sufficient physico-chemical stability of the formulation,
and also resistance of the formulation to microbial growth over
time during storage and use. There are many liquid dietary
supplements containing calcium and magnesium compounds that are
commercially available or described in prior literature. However,
to the inventor's knowledge there are no prior art examples of
aqueous liquid formulations that have relatively high
concentrations (e.g. at least 1 Molar) of dissolved calcium and
magnesium compounds in combination, are reasonably stable, and also
have inherent resistance to microbial growth in the absence of
additional preservatives. The present invention discloses
formulation compositions that have these aforementioned
characteristics, and therefore are new and useful compositions not
previously available in prior art. Although it is possible to add
optional preservatives to the formulations described in this
invention, a very useful feature of these formulations is an
inherent resistance to microbial growth and thus the need for
adding preservatives can be reduced, minimized or eliminated. This
in turn makes the formulation compositions simpler, more versatile,
and more suitable for regular use.
In order to achieve this inherent resistance to microbial growth,
the formulation compositions of this invention contain calcium and
magnesium compounds dissolved at suitable concentrations in water
such that the sum of the concentrations of the dissolved calcium
compound(s) and dissolved magnesium compound(s) is at least about 1
molar, more preferably at least about 1.5 molar, and most
preferably at least about 2 molar or more, up to the point of
saturation.
In another embodiment, the formulation composition comprises
dissolved calcium compound(s) and dissolved magnesium compound(s)
in a range of about 1 molar to saturation along with excess
undissolved solids being present, as in a suspension, or
undissolved non-aqueous liquid droplets being present, as in an
emulsion. Although fully dissolved and clear liquid formulations
are preferable, the compositions of the invention have useful
characteristics such as beneficial amounts of dissolved calcium and
magnesium, along with inherent microbial resistance, even if some
ingredients are present that are poorly soluble. Thus the calcium
& magnesium compositions of this invention can be considered as
useful liquid vehicles for the delivery of additional nutritional
compounds, whether those additional compounds are sufficiently
water soluble or not.
F. Kits of the Invention
The compositions of the present invention may be utilized in kits
as described herein. The kits of the present invention comprise one
or more compositions of the present invention together with
information which informs a user of the kit, by words, pictures,
and/or the like, that use of the kit will provide supplementation
of a beverage or food with calcium and magnesium, and with
additional beneficial compounds where applicable.
In a particularly preferred embodiment, the information is printed
on a container holding the composition, e.g., a bottle. These
preferred kits may be in the form of one bottle containing the
composition, or may be obtained as a plurality of bottles each
containing the composition. For example, the kits may be obtained
as one bottle, or cases of four, six, seven, or eight bottles
co-packaged together. The preferred kits may also include one or
more dispensing means, such as dispensing cap, dropper, syringe,
dispensing pump, small measuring cup, or spoon, for providing a
measured amount of the formulation into a cup or other suitable
quantity of water, juice, other beverage, or food. The preferred
kits may also include instructions for dispensing and mixing the
composition into a beverage or food. In another preferred
embodiment, a kit may provide a large quantity of a formulation
composition of the present invention to be utilized during
manufacture of a fortified beverage or food, for subsequent
distribution. In another embodiment, a kit may comprise one or more
of the formulation composition(s) of the present invention,
containing instructions to use in combination with, or preferably
co-packaged with, one or more commercially available dietary
supplements) such as a vitamin product, a multivitamin product, a
mineral product, a trace mineral product, a herbal product etc.
G. Methods of the Invention
The formulation compositions described in this invention comprise
calcium and magnesium compounds dissolved in water, wherein the sum
of the concentrations of these compounds is about 1 molar or more,
and wherein additional optional ingredients may be present. Several
embodiments of the compositions have already been described. Some
practical uses are described below.
The compositions may be used to mineralize drinking water with
calcium and magnesium compounds, along with other optional
minerals, vitamins or other ingredients that are beneficial for
health. This is especially useful when the water to be mineralized
is deficient in minerals, such as in the case of distilled or
reverse-osmosis filtered waters, rain water, etc. Mineralizing of
water is achieved by adding small quantities of the formulation
compositions to drinking water.
There are many methods by which a formulation of this invention can
be added to water or other beverages. For example, the formulation
may be dispensed directly from a bottle thru a dispensing cap, or
it may be added to the water using a dropper, syringe, spoon, small
measuring cup, dispensing pump etc. The quantity to be added
depends on the amount of water that needs to be mineralized, and
the level of mineralization required. Since the formulations of
this invention are aqueous liquids, mixing with water is easily
achieved. If needed, some mechanical mixing may be employed to
provide a homogenous solution of the mineralized water.
The formulations described in this invention can also be used as a
dietary supplement to increase intake of calcium, magnesium and
other optional beneficial ingredients that may be present in the
formulation. Using the supplement in this manner is especially
useful when the individual taking the supplement has a calcium
and/or magnesium mineral deficiency, or has a diet or condition
that can lead to such deficiencies. Since the formulations have
high concentrations of calcium and magnesium compounds, they are
intended to be ingested only after dilution into water, juice or
some other beverage, soup, food or meal. This is achieved simply by
adding a measured amount of the formulation into a cup or other
suitable quantity of water, juice or other beverage, soup, food or
meal. The measured amount of the formulation composition added to
the cup of beverage or serving of food may be at least about 1
.mu.l, preferably at least about 5 .mu.l, more preferably at least
about 25 .mu.l, and most preferably at least about 50 .mu.l, which
is the approximate volume of one water drop. The measured amount of
the formulation composition added to the cup of beverage or serving
of food may be up to about 60 ml (4 tablespoons), preferably up to
about 30 ml (2 tablespoons), more preferably up to about 15 ml (1
tablespoon), still more preferably up to 10 ml (2 teaspoons), and
most preferably up to about 5 mls (1 teaspoon).
The formulations of this invention can also be prepared and used at
a large scale. For example, measured amounts of formulation can be
added to a large vessel or tank to mineralize water, or to
manufacture a dietary supplement or fortified food. During such
manufacturing processes, the formulations can be added by either
weight or volume, on a continuous or intermittent basis, manually
or by using a metering device.
The calcium and magnesium formulations described in this invention
can also be used as a base or vehicle for dietary supplement
formulations with additional optional ingredients. The added
ingredients would provide additional desirable characteristics to
the basic formulations, such as including additional beneficial
minerals, vitamins, antioxidants, herbal extracts, flavonoids,
bracers, and/or other beneficial ingredients, including pleasant
flavors, visually attractive colors, etc. As a simple illustration
of this, some of the formulations described in Examples 2 and 3
provide the beneficial mineral potassium, along with calcium and
magnesium.
The methods of the invention also include methods of designing a
formulation composition. In one embodiment, the invention provides
a method of designing an aqueous composition comprising one or more
dissolved calcium compound(s) and one or more dissolved magnesium
compound(s), comprising: a. Selecting one or more calcium
compound(s) and one or more magnesium compound(s) for the
composition; and b. Determining the amounts of the individual
calcium and magnesium compounds to be included in the composition
so that the sum total dissolved concentration of the calcium and
magnesium compound(s) is at least about 1 molar, preferably at
least about 1.5 molar, and more preferably at least about 2 molar.
c. Optionally, selecting or determining amounts of one or more
optional ingredient(s) so that these are compatible with the
dissolved calcium and magnesium formulations.
The methods of the invention include methods of preparation or
manufacture. Various processes may be used to prepare the
compositions that have been described. Preferably the compositions
are prepared by one or more simple processes comprising dissolution
or mixing of the ingredients into water. However other processes
may also be employed. Non-limiting examples of commonly used
processes may include mixing of ingredient(s) into au aqueous
solution; mixing of one or more aqueous solution(s); removal of
water from dilute composition(s) by evaporation, dialysis,
ultrafiltration or freeze-drying to reach the desired
concentrations of the calcium and magnesium compounds and optional
ingredients; and by utilizing combinations of these processes.
Further, in the case of poorly soluble optional ingredient(s),
solubilization, suspension and/or emulsification processes may be
employed.
In the methods of designing or manufacturing compositions of the
invention, non-limiting examples of the compounds that may be
selected include one or more of the calcium compounds, the
magnesium compounds, or the optional compounds listed earlier in
Section C of the detailed description.
H. Additional Embodiments of the Invention
Based on the prior sections, additional non-limiting embodiments of
the present inventions are described below:
31x. A method of fortifying a beverage or food with calcium and
magnesium comprising:
adding at least about 1 .mu.l up to about 60 ml of the composition
of embodiment 1x to about one cup of the beverage or about one
serving of the food, or adding correspondingly larger or smaller
amounts of the composition to larger or smaller quantities of the
beverage or food.
32x. A method of fortifying a beverage or food with calcium and
magnesium comprising:
adding at least 1 drop or about 50 .mu.l, up to about 30 ml of the
composition of embodiment 1x to one cup of the beverage or one
serving of the food, or adding correspondingly larger or smaller
amounts of the composition to larger or smaller quantities of the
beverage or food.
33x. A method of fortifying a beverage or food with calcium,
magnesium and additional optional ingredient(s), comprising:
adding at least 1 drop or about 50 .mu.l, up to about 30 ml of the
composition of embodiment 20x to one cup of the beverage or one
serving of the food, or adding correspondingly larger or smaller
amounts of the composition to larger or smaller quantities of the
beverage or food.
34x. A method of designing an aqueous composition comprising one or
more dissolved calcium compound(s) and one or more dissolved
magnesium compound(s), comprising:
a. selecting one or more calcium compound(s) and one or more
magnesium compounds) to be included in the composition; and
b. selecting or determining the amounts of the individual calcium
and magnesium compounds to be included in the composition so that
the dissolved compounds remain soluble and compatible upon storage
at room temperature, while the sum total concentration of the
calcium compound(s) and the magnesium compound(s) is at least about
1 molar.
35x. The method of embodiment 34x, wherein one or more additional
ingredient(s) are included within the composition by a) selecting
one or more additional ingredient(s) to be included within the
composition and b) selecting or determining the amount(s) of the
additional ingredients such that the dissolved compound(s) remain
soluble and compatible upon storage at room temperature.
36x. The method of embodiment 34x, wherein one or more additional
ingredient(s) are included within the composition by a) selecting
one or more additional ingredient(s) to be included within the
composition and b) selecting or determining the amount(s) of the
additional ingredient(s) such that the additional ingredient(s) are
dissolved, solubilized, emulsified or suspended within the
composition.
37x. The method of embodiment 34x, wherein the one or more calcium
compound(s) are selected from calcium chloride, calcium acetate,
calcium amino acid complexes, calcium aminoethyl phosphate, calcium
arginate, calcium aspartate, calcium ascorbate, calcium citrate,
calcium glubionate, calcium gluceptate, calcium gluconate, calcium
bromide, calcium iodide, calcium lactate, calcium malate, calcium
orotate, and calcium pyruvate; and the one more dissolved magnesium
compound(s) are selected from magnesium chloride, magnesium
acetate, magnesium amino acid complexes, magnesium arginate,
magnesium aspartate, magnesium ascorbate, magnesium citrate,
magnesium gluconate, magnesium glycinate, magnesium lactate,
magnesium lysinate, magnesium malate, magnesium orotate, magnesium
bromide, magnesium iodide, magnesium pyruvate and magnesium
succinate
38x. A method of manufacture of the composition of embodiment 1x,
wherein the composition is prepared by a process comprising one or
more of: mixing of ingredient(s) into water or aqueous solution;
mixing of one or more aqueous solutions; or removal of water from
dilute composition(s) by evaporation, dialysis, ultrafiltration, or
freeze-drying.
39x. A method of manufacture of the composition of embodiment 20x,
wherein the composition is prepared by a process comprising one or
more of: mixing of ingredient(s) into water or aqueous solution;
mixing of one or more aqueous solution(s); removal of water from
dilute composition(s) by evaporation, dialysis, ultrafiltration, or
freeze-drying; incorporation of poorly soluble ingredient(s) by
solubilization; incorporation of poorly soluble Liquid
ingredient(s) by emulsification; or incorporation of poorly soluble
solid ingredient(s) by suspension.
40x. A kit comprising the composition of embodiment 1x
41x. A kit comprising the composition of embodiment 20x.
42x. A kit comprising the embodiment of 1x or 20x, copackaged with
one or more commercially available vitamin product, multivitamin
product, mineral product or herbal product.
EXAMPLES
The examples provided below explain the compositions of the
invention further, and also demonstrate several of the embodiments.
The examples are illustrative only, and variations may be made in
the specific compositions as described within the scope of this
application.
Example 1
Twenty five formulations were made with different concentrations of
calcium chloride and magnesium chloride dissolved in distilled
water. The formulations contained various ratios of elemental
calcium to elemental magnesium in the formulations, as shown in
Table 1. For each of these ratios, formulations were prepared at a
total concentration (sum of calcium and magnesium compound
concentrations) of 1M, 1.5M, 2.0M, 2.5M, and 3.0M. All the
formulations were visually clear, demonstrating full dissolution of
the calcium and magnesium compounds. A bacterial suspension of E.
coli was spiked into aliquots of each of these 25 formulations and
mixed. A positive control was also prepared, by spiking and mixing
the same E. coli suspension in distilled water. The spiked samples
were incubated for 1 day at room temperature, and dilutions were
then plated on Petrifilm plates (designed for total aerobic counts)
to evaluate microbial growth or inhibition. The results are
summarized in Table 1. Relative to the positive control, microbial
growth was somewhat reduced (approx 2-fold) in the formulations
having a total calcium & magnesium compound concentration of
1M. In contrast, microbial growth was significantly reduced
(approx. 10-fold reduction) in the formulations having total summed
concentration of 1.5 M. The microbial count reduction observed was
approx 100-fold or greater, and practically no bacterial counts
were observed for the spiked formulations where the sum of the
calcium and magnesium compounds was 2M, 2.5M or 3M, irrespective of
the ratio of calcium to magnesium.
TABLE-US-00001 TABLE 1 Calcium Magnesium Total % RDA* chloride
chloride Calcium to salt in Formulation concentration concentration
Magnesium conc. Visual Microbial 5 ml Code (M) (M) ratio (M)
appearance inhibition (Ca, Mg) CM2A1.0 0.76 0.24 3.2 1.0 Clear
Slight 15, 7 CM2B1.0 0.6 0.4 1.5 1.0 Clear Slight 12, 12 CM2C1.0
0.5 0.5 1.0 1.0 Clear Slight 10, 15 CM2D1.0 0.4 0.6 0.7 1.0 Clear
Slight 8, 18 CM2E1.0 0.24 0.76 0.3 1.0 Clear Slight 5, 23 CM2A1.5
1.14 0.36 3.2 1.5 Clear Significant 23, 11 CM2B1.5 0.89 0.61 1.5
1.5 Clear Significant 18, 18 CM2C1.5 0.75 0.75 1.0 1.5 Clear
Significant 15, 23 CM2D1.5 0.61 0.89 0.7 1.5 Clear Significant 12,
27 CM2E1.5 0.36 1.14 0.3 1.5 Clear Significant 7, 35 CM2A2.0 1.52
0.48 3.2 2.0 Clear High 31, 14 CM2B2.0 1.19 0.81 1.5 2.0 Clear High
24, 25 CM2C2.0 1.0 1.0 1.0 2.0 Clear High 20, 30 CM2D2.0 0.81 1.19
0.7 2.0 Clear High 16, 36 CM2E2.0 0.48 1.52 0.3 2.0 Clear High 10,
46 CM2A2.5 1.9 0.6 3.2 2.5 Clear High 38, 18 CM2B2.5 1.49 1.01 1.5
2.5 Clear High 30, 31 CM2C2.5 1.25 1.25 1.0 2.5 Clear High 25, 38
CM2D2.5 1.01 1.49 0.7 2.5 Clear High 20, 45 CM2E2.5 0.6 1.9 0.3 2.5
Clear High 12, 58 CM2A3.0 2.29 0.71 3.2 3.0 Clear High 46, 22
CM2B3.0 1.79 1.21 1.5 3.0 Clear High 35, 37 CM2C3.0 1.5 1.5 1.0 3.0
Clear High 30, 46 CM2D3.0 1.21 1.79 0.7 3.0 Clear High 24, 54
CM2E3.0 0.71 2.29 0.3 3.0 Clear High 14, 69 *RDA: recommended daily
allowance, based on a standard 2000 calorie diet
Example 2
Sixteen formulation compositions were prepared in four sets as
described below, and shown in Table 2. The first set of
formulations was prepared with calcium chloride and magnesium
acetate dissolved in distilled water. The second set was prepared
with calcium acetate and magnesium chloride dissolved in distilled
water. The third set was prepared with calcium chloride, magnesium
chloride, calcium acetate and magnesium acetate dissolved in
distilled water. The fourth set was prepared with calcium chloride,
magnesium chloride, and potassium chloride dissolved in distilled
water. Within each set, four formulations were prepared at a total
summed calcium and magnesium compound concentration of 1M, 1.5M,
2.0M, and 2.5M. All formulations were visually clear, demonstrating
full dissolution of the compounds. A bacterial suspension of E.
coli was spiked into aliquots of each of these 16 formulations and
mixed. A positive control was also prepared, by spiking and mixing
the same E. coli suspension in distilled water. The spiked samples
were incubated for 1 day at room temperature, and dilutions were
then plated on Petrifilm plates (designed for total aerobic counts)
to evaluate microbial growth or inhibition. The results are
summarized in Table 2. Relative to the positive control, microbial
growth was somewhat reduced (approx 2-fold) in the formulations
having a total summed concentration of 1M. In contrast, microbial
growth was significantly reduced (approx 10-fold) in the
formulations having total summed concentration of 1.5 M. Further,
the microbial count reduction was approx 100-fold or greater, and
there were practically no bacterial counts observed for the spiked
formulations where the sum of the calcium and magnesium compounds
was 2M or 2.5M, irrespective of the ratio of calcium to magnesium,
or the specific type of compound used. These results were
consistent with the results seen earlier in Example 1, and show
that the formulations behaved consistently when other compounds of
calcium and magnesium were used in various combinations, and also
when an additional optional compound was added. Further, the 16
formulations were passed thru a 0.2 micron pore-size filter to
remove any extraneous particulates, and stored at room temperature
in plastic tubes with caps. They were inspected after 3 months and
then again after 13 months, and all the formulations remained clear
and soluble, with no evidence of microbial growth.
TABLE-US-00002 TABLE 2 Calcium Magnesium Ca & Mg % RDA
CaCl.sub.2 MgCl.sub.2 acetate acetate KCl salts sum in Formula
conc. conc. conc. conc. conc. conc. Visual Microbial 5 ml Code (M)
(M) (M) (M) (M) (M) Appearance inhibition (Ca, Mg) CM3A1.0 0.67 --
-- 0.33 -- 1.0 Clear Slight 13, 10 CM3A1.5 1.0 -- -- 0.5 -- 1.5
Clear Significant 20, 15 CM3A2.0 1.34 -- -- 0.66 -- 2.0 Clear High
27, 20 CM3A2.5 1.67 -- -- 0.83 -- 2.5 Clear High 33, 25 CM4A1.0 --
0.67 0.33 -- -- 1.0 Clear Slight 7, 20 CM4A1.5 -- 1.0 0.5 -- -- 1.5
Clear Significant 10, 30 CM4A2.0 -- 1.34 0.66 -- -- 2.0 Clear High
13, 41 CM4A2.5 -- 1.67 0.83 -- -- 2.5 Clear High 17, 51 CM5A1.0 0.4
0.4 0.1 0.1 -- 1.0 Clear Slight 10, 15 CM5A1.5 0.6 0.6 0.15 0.15 --
1.5 Clear Significant 15, 23 CM5A2.0 0.8 0.8 0.2 0.2 -- 2.0 Clear
High 20, 30 CM5A2.5 1.0 1.0 0.25 0.25 -- 2.5 Clear High 25, 38
CM6A1.0 0.5 0.5 -- -- 0.25 1.0 Clear Slight 10, 15 CM6A1.5 0.75
0.75 -- -- 0.3 1.5 Clear Significant 15, 23 CM6A2.0 1.0 1.0 -- --
0.4 2.0 Clear High 20, 30 CM6A2.5 1.25 1.25 -- -- 0.5 2.5 Clear
High 25, 38
Example 3
Two formulations were prepared in distilled water, with even
greater concentrations of calcium and magnesium compounds as
compared to prior examples (total summed concentration of about 4.2
M) as compared to the earlier examples. It should be noted that the
formulations presented in this example are close to the point of
saturation. One of these formulations was prepared with calcium
chloride and magnesium chloride; and the other formulation included
a third compound (potassium chloride) along with the calcium and
magnesium compounds, as shown in Table 3. It should be noted that
inclusion of the potassium compound within one of the formulations
demonstrates inclusion of an additional optional ingredient. The
formulations were passed thru a 0.2 micron pore-size filter to
remove any extraneous particulates, and stored at room temperature
in plastic bottles with dispensing caps. These formulations were
tested a) for mineralizing reverse-osmosis (RO) filtered drinking
water, and b) for dietary supplementation. Mineralization of water
was accomplished by adding one or more drop(s) of formulation to an
empty cup of water, and then filling the cup with RO filtered, or
distilled water. Mineralized water consistently tasted better
(normal) as compared to RO filtered or distilled waters, due to the
presence of added minerals. The presence of added minerals was
confirmed by conductivity measurements to estimate total dissolved
solids (TDS). Typically, the TDS value of RO filtered water was 5
ppm and the TDS value of distilled water was less than 1 ppm. The
addition of a single drop (approx 50 .mu.L) of any one of the two
formulations of this example to a standard size 8 oz. cup of RO or
distilled water resulted in a TDS of about 100 ppm. Additional
dietary supplementation of calcium and magnesium was accomplished
in a manner similar to the mineralization of water, by adding
larger quantities (up to one teaspoon) of formulation to a cup of
water or juice, and then drinking the entire contents. The
formulations taken in this manner had a distinct taste when diluted
in water. However, the taste was masked when diluted in juice.
The formulations were inspected after 3 months and remained as
clear liquids, with no evidence of microbial growth. The
formulations were inspected again after 13 months, and remained
clear liquids with no evidence of microbial growth. Since these
formulations contain simple compounds of calcium and magnesium,
there is no concern of any chemical degradation. Since these
formulations also inhibit any microbial growth, they are expected
to have a long shelf life of several years when stored in closed
containers, and refrigeration is not needed. Thus these
formulations are physically and chemically stable, do not allow
bacterial growth, and are convenient to store and use.
TABLE-US-00003 TABLE 3 Typical TDS* (ppm) of % RDA of mineralized
Calcium, Visual water, after Magnesium, appearance Microbial adding
2 drops Potassium CaCl.sub.2 MgCl.sub.2 KCl after 13 growth after
(approx 100 .mu.L) in Formula conc. conc. conc. months 13 months of
formulation to 1 teaspoon Code (M) (M) (M) storage storage 8 oz
RO** water (5 ml) CM1 2.5 1.65 -- Clear No 205 50, 50, NA CMK1 2.5
1.65 0.45 Clear No 220 50, 50, 2.5 *TDS: Total dissolved solids,
based on conductivity (with sodium chloride reference) **RO water:
reverse-osmosis filtered (purified and demineralized) water. TDS of
RO water was typically 5 ppm.
Example 4
Two drops of formulation CM1 mentioned in Table 3 are added to one
8 oz cup of water. Drinking 8 such cups of mineralized water a day
will provide about 8% of the recommended intake of calcium and
magnesium, based on a standard 2000 calorie diet. If two drops of
formulation CMK1 mentioned in Table 3 are used instead of CM1,
drinking 8 such cups of mineralized water a day will provide about
8% of the recommended intake of calcium and magnesium, along with a
trace quantity of potassium, which also helps to slightly improve
the water taste.
Example 5
In the case of formulation CMK1 mentioned in Table 3, 1 teaspoon is
added into a cup of water. Consuming the entire contents of the cup
will provide 50% of the recommended daily intake amount of calcium
and magnesium, along with about 2.5% of the recommended intake of
potassium, based on a standard 2000 calorie diet. Alternatively,
the formulation is added to a cup of juice or beverage, or added to
a serving of soup or some other suitable food, if taste masking of
the formulation ingredients is desired. As described in an earlier
section, it is also possible to add sweeteners or flavors for
improved taste. Further, as described in an earlier section, a
variety of optional ingredients may be added to the basic calcium
and magnesium compositions described in this and the earlier
examples. Therefore, the calcium and magnesium compositions of the
invention, described in earlier embodiments and within the examples
shown in the above tables, serve as a useful base vehicle for
additional ingredients, allow convenient storage while inhibiting
microbial growth, and allow consumption in a convenient manner
while providing useful minerals along with additional dietary
ingredients.
The examples provided in the above section demonstrate several of
the embodiments, and also provide several variations of the
formulation compositions of the invention. Further, formulations
within the scope of the invention can be varied easily by changing
concentrations of calcium or magnesium compounds, and by adding
additional optional ingredients. Variations or alternative
embodiments of the present invention will be obvious to those
skilled in the art and it is intended that these variations are
within the scope of the present invention.
What has been described and illustrated herein are preferred
embodiments of the invention along with some variations. The terms
and descriptions used herein are set forth by way of illustration
only and are not meant as limitations. Those skilled in the art
will recognize that many variations are possible within the spirit
and scope of the invention in which all terms are meant in their
broadest, reasonable sense unless otherwise indicated. Any headings
utilized within the description are for convenience only and have
no legal or limiting effect.
* * * * *
References